Standardized molecular diagnostic testing for vitreoretinal lymphoma
Official title: DECODE VRL - Multicentric Implementation and Clinical Validation of Standardized, Innovative Molecular Diagnostics for VitreoRetinal Lymphoma
Run by University of Luebeck · NCT05841914 · Data updated 2026-11-12
This project will test whether centralized molecular testing of eye and blood samples can help doctors diagnose and monitor adults with suspected vitreoretinal lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | University of Luebeck Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Status | Recruiting |
| Started | June 1, 2023 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2028 |
| Registry record updated | July 23, 2025 |
| Trial ID | NCT05841914 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with clinical suspicion of vitreoretinal lymphoma who are scheduled for diagnostic vitrectomy and can provide informed consent are eligible for inclusion.
✕Probably not a fit
Patients who recently received systemic chemotherapy (within 3 months), recent systemic corticosteroids (within 2 weeks), who cannot undergo vitrectomy, or whose disease is ultimately not VRL may not benefit from the molecular testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, multicentre observational project will collect aqueous, vitreous, blood serum and occasional retinal/choroidal samples from at least 220 adults with suspected vitreoretinal lymphoma. Diagnostic samples will be processed centrally using a standardized pipeline and subjected to multiparametric molecular analyses including next-generation sequencing for mutations and clonality detection and miRNA profiling. Patients will be followed for up to 24 months to link molecular biomarkers with diagnostic outcomes and treatment response. The aim is to determine whether standardized molecular diagnostics improve diagnostic sensitivity and provide useful monitoring biomarkers compared with current standard work-up.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate diagnoses and give clinicians better tools to monitor treatment response in vitreoretinal lymphoma.
How similar studies have gone: Molecular methods such as NGS, clonality testing, and miRNA profiling have shown promise in retrospective series, but prospective multicentre validation in VRL is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical suspicion of the presence of VRL with indication for diagnostic vitrectomy. Clinical suspicion is based on the assessment of the treating physicians in the clinics participating in this study. * Age over 18 years. * Written informed consent to participate in the study. Exclusion Criteria: * Systemic chemotherapy for lymphoma within 3 months prior to vitrectomy. * Cortisone use within 2 weeks before vitrectomy, macular oedema, posterior synechiae, rubeosis iridis
Where it's running
-
University Clinic of Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany Recruiting
Study contacts
- Study coordinator: Liv Dollmann
- Email: liv.dollmann@uksh.de
- Phone: +49451-500-50868
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.